Naltrexone Neuroimaging in Teens With Eating Disorders

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age13-21
SponsorChildren's Mercy Hospital Kansas City

About this trial

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

Eligibility criteria

Qualifiers

Adolescents and young adults aged 13-21 years

Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.

Stable medication regimen (no dose or drug changes in the past 4 weeks)

Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study

Disqualifiers

Pregnant (via UCG)

Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)

Non-removable metal in the body that is magnetic resonance imaging incompatible

Current naltrexone use

Trial design

Treatments tested in this trial

  • Naltrexone
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Mercy Hospital Kansas City

Lead sponsor

University of Kansas Medical Center

Collaborator

National Institute of Mental Health (NIMH)

Collaborator